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FDA 510(k) Application Details - K242063
Device Classification Name
Percussor, Powered-Electric
More FDA Info for this Device
510(K) Number
K242063
Device Name
Percussor, Powered-Electric
Applicant
Synchrony Medical Ltd.
8 Ariel Sharon
Or Yehuda 6037607 IL
Other 510(k) Applications for this Company
Contact
Anat Shani
Other 510(k) Applications for this Contact
Regulation Number
868.5665
More FDA Info for this Regulation Number
Classification Product Code
BYI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/15/2024
Decision Date
12/19/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K242063
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